Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia (QUALITY BIS)

Schizophrenia is a severe and persistent psychological disorder affecting 0.7 to 1% of the world's population and 600,000 people in France. Schizophrenic patients are exposed to excess mortality and a life expectancy that is 10 to 15 years lower than the general population (excluding causes of suicide) and to numerous co-morbidities, including oral diseases.

To improve this public health problem, concrete action must be undertaken and evaluated in both quantitative and qualitative terms. While there are many quantitative indicators, there are no reliable and valid tools for the perceived oral health of these individuals in the context of their real and/or imagined world.

The results of a qualitative study previously carried out by our team (QUALITY Study: NCT02730832) made it possible to develop two hypothetical questionnaires for evaluating quality of life related to oral health, the Schizophrenia Oral Health Profile (SOHP), and a questionnaire for evaluating coping strategies with regard to oral health, the Schizophrenia Coping Oral Health Profile (SCOOHP).

However, before these questionnaires can be used in clinical practice, their psychometric properties must be validated.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: Questionnaires; Procedure: Oral examination; Other: questionnaires (test-retest)

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis

Description

Inclusion Criteria:

• Adult person,
• Patients for whom a diagnosis of schizophrenia is defined according to ICD 10
• Person who has given his or her oral agreement to participate in the study, with the agreement of the tutor in the context of a tutorship,
• Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis,
• Fluent use of the French language.

Exclusion Criteria:

• Psychiatrically unstable and delusional patients.
• Patients with cognitive abilities too impaired to participate in the study
• Individuals with no natural teeth
• Pregnant or breastfeeding women
• Patients not affiliated to the national health insurance system.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients	Other: Questionnaires; A validated oral health-related quality of life self-assessment questionnaire: the GOHAI; A validated oral health-related quality of life self-assessment questionnaire to be validated: SOHP; A validated depression scale: the Beck scale; A self-assessment questionnaire for oral health coping to be validated: the SCOOHP; A validated self-assessment questionnaire for coping: The Brief cope); Procedure: Oral examination; An evaluation of dental health using the CAO index; An evaluation of oral hygiene with the IHO-S index
Voluntary patients	Other: Questionnaires; A validated oral health-related quality of life self-assessment questionnaire: the GOHAI; A validated oral health-related quality of life self-assessment questionnaire to be validated: SOHP; A validated depression scale: the Beck scale; A self-assessment questionnaire for oral health coping to be validated: the SCOOHP; A validated self-assessment questionnaire for coping: The Brief cope); Procedure: Oral examination; An evaluation of dental health using the CAO index; An evaluation of oral hygiene with the IHO-S index; Other: questionnaires (test-retest); SCOOHP and SOHP questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reliability of scales (internal consistency)	through study completion, an average of 18 months
validity of scales (consistency of responses)	through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): July 9, 2021
• Study Completion (ACTUAL): July 9, 2021

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: DENIS 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No